Drug sponsors know very well how essential it is to establish the TPP (Target Product Profile) of their prospective drug product as early as possible.

A TPP is, simply, a plan of action for a pharmaceutical development program, communicating the desired attributes of the product and formulation to all stakeholders, whether drug sponsors, regulators, developers or manufacturers. It is critical to determine a product’s eventual commercial formulation, and is also a key step in protecting pharmaceutical IP (intellectual property).

Given all of this, it is basic common sense to develop a robust and attainable TPP before you start any development project. Nevertheless, taking a product concept described in a TPP from lab to patient is easier said than done. Here, Chris Rojewski, Pfizer CentreOne Regulatory Affairs, explains why it is important to unite a TPP with a comprehensive regulatory strategy and pharmaceutical regulatory support.

The secret to TPP and regulatory strategy success

Whether you are engaging in a small-molecule or large-molecule development project, a TPP is critical in order to ensure that all involved have a clear idea of why the proposed formulation and finished form are improvements over an existing drug product.

When developing a TPP, you should keep your product’s commercial objectives front of mind, weighing them against the drug’s pharmacology and clinical development necessities to describe an optimized but market-realistic view of your goals.

Best practice for creating a robust TPP calls for the development of three initial product descriptions:

1. Weak. A worst-case scenario for a minimally compliant product.
2. Acceptable. Describes the middle ground that is the most likely outcome.
3. Strong. The best-case scenario of what you want to claim on the final label.
   In addition to these product descriptions, you need a regulatory strategy to align your proposed pharmaceutical development plan with business objectives. The purpose of this is to identify any regulatory risks it may present so you can broaden distribution globally and increase patient access to your innovation.

All strong regulatory strategies feature a common set of principles:

1. Anticipatory
2. Quantification of risks
3. Forward and backward thinking
4. Regionally, globally agnostic
   Taking all of these in to account, you can begin to plan and launch the program laid out in your TPP.

Seeking regulatory support

From a drug developer’s perspective, pharmaceutical development program management, including the development of their regulatory strategy, is best left to experts. Most often, this means RA (Regulatory Affairs) consultants or similar specialized resources within their CDMO (contract development and manufacturing organization) partners.

Historically, many CDMOs have offered RA services to support client programs, but not necessarily comprehensively enough to meet the expanding needs of pharma’s “developer-class” of companies. However, a growing number of CDMOs are recognizing that comprehensive regulatory strategy is the secret ingredient of any successful project.

More and more CDMOs are offering a service that includes strategy, submission, authoring, publication of submission, lifecycle management and market expansion support, as well as the creation of documentation required for all CTD Modules (1-5). This kind of support is helping drug sponsors of all shapes and sizes to achieve their objectives detailed in their TPP.

Finding the right CDMO partner

When assessing CDMO partners’ RA offering, you should consider a number of factors:

• A CDMO that offers all of the above...
• Is the RA offering fully integrated?
• Does the RA team have demonstrable experience in addressing CMC risk mitigation and other early RA strategic needs?
• Can the team publish your regulatory submission securely and compliantly, and submit or speak on your behalf?
• Can the team respond to regulatory enquiries quickly and efficiently when needed?
• Can the RA team provide lifecycle management support for your regulatory submission, and support global market expansion and renewal?
  A CDMO that offers all of the above in addition to product development and commercialization will be well worth partnering with, helping you manage regulatory risk at a more affordable price point than hiring a separate partner.

Regulatory strategy is integral to effective drug strategy

Whether you are engaged in small-molecule development or large-molecule development, you need a drug strategy that incorporates regulatory strategy from the beginning. This is essential to meet the objectives of your TPP and to ensure efficient and effective long-term lifecycle management.

CDMOs play a growing role in pharmaceutical development and manufacturing. They can also support drug sponsors and IP owners in managing regulatory issues. By working with them in this area, pharma’s innovators can ensure they have an effective drug strategy in place to achieve commercial success.

To find out more about our regulatory affairs support, click here.